The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.

There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.

Eligibility

Ages Eligible for Study:

30 Years to 79 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Aged 30 to 79 years

With blood pressure being >150/>90 if they are not on any antihypertensive treatment

With blood pressure being >140/>90 if they are already on antihypertensive drugs

No history of type 2 diabetes

No history of gout

Exclusion Criteria:

With supine blood pressure being >200/>120

Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified

Patients already on thiazide diuretics

With type 2 diabetes

With gout or hyperuricaemia (>8.0 mg/dl)

With hypokalemia（<3.5mmol/L）

With erectile dysfunction

With renal dysfunction (s-creatinine > 2.0 mg/dL)

With history of serious adverse reaction to thiazide diuretics

With history of stroke or myocardial infarction within 6 months

With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned

With heart failure or left ventricular dysfunction (ejection fraction<40%)

Patients who should be on thiazide diuretics

With history of malignant tumor within 5 years

Pregnant, possibility of pregnancy, or during breast feeding

Patients who are deemed not eligible for this study for any reason

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131846

Locations

Japan

University of the Ryukyus

Nishihara-cho, Okinawa, Japan, 903-0215

Sponsors and Collaborators

Kyoto University

University of the Ryukyus

Investigators

Principal Investigator:

Shinichiro Ueda, MB, ChB, PhD

Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus